Antibacterial agent, and device used for active protection of incision margins and incorporating such an antibacterial agent

ABSTRACT

Antibacterial agents comprise as an active ingredient a hemostatic contact cloth having an acidic pH combined with povidone iodine. Also disclosed are surgical dressings. Also disclosed are devices for active protection of incision margins.

TECHNICAL FIELD OF THE INVENTION

An object of the present invention is an antibacterial agent comprisingas an active ingredient a hemostatic contact cloth having an acidic pHcombined with povidone iodine. It also relates to an active protectiondevice for incision margins incorporating such an antibacterial agent.

The invention relates to the technical filed of antibacterial agentsdesigned to be used in humans and/or animals in order to protect and/ortreat a wound and/or incision against bacterial infections. It alsorelates to the technical field of surgical accessories enablingprotection of the incision margins during a surgical operation. Theinvention relates more particularly to the technical field of surgicaldrapes.

PRIOR ART

Hemostatic contact cloths are usually used for the treatment ofhemorrhages, uncontrollable by conventional techniques, either cutaneousor internal (capillary and venous or arterial hemorrhages; oozingbleeding; cardiac and vascular surgery, neurosurgery; urology; . . . ).

By design, these hemostatic cloths typically have acidic pH so that theyindirectly have an antibacterial activity. However, manufacturersrecommend not using it for antibacterial purposes. In practice, theantibacterial activity must be carried out by an agent specificallydesigned for this purpose.

Povidone iodine (or polyvinylpyrrolidone iodine) is an external agentthat liberates inorganic iodine acting directly on the cytoplasmicproteins to the state of free iodine. Povidone iodine is known for itsantibacterial, antiseptic or antifungal properties. Although extremelyeffective, povidone iodine has a limited use because it does not enabletreatment of all strains of germs that can cause antiseptic/antibioticcross-resistances.

Known from the document SPALNGLER et al: “In Vitro AntimicrobialActivity of Oxidized Regenerated Cellulose Against Antibiotic-ResistantMicro-Organisms” SURGICAL INFECTIONS, vol. 4, No. 3, 2003, pages255-262, is the result of an in-vitro study regarding the antimicrobialactivity of oxidized regenerated cellulose materials. This studydemonstrates the effectiveness of oxidized regenerated cellulose onmicro-organisms resistant to multiple antibiotics, and more particularlythe importance of an acidic pH. This study does not however make mentionof the antimicrobial combination between the oxidized regeneratedcellulose and povidone iodine.

A first technical problem the invention aims to resolve is to offer anew agent having an antibacterial activity superior to that of ahemostatic cloth and superior to that of povidone iodine, in order to becapable of treating a wide range of strains of germs and in particularcertain germs resistant to antibiotics.

Also, during surgical operations, it is common to use surgical drapesprovided with incision windows through which surgical procedures areperformed. These drapes are placed on the skin of the patient and havethe purpose or isolating and protecting the incision area against anycontamination. They form an effective barrier between the body of thepatient and the atmosphere of the operating room.

The surgical drapes usually used are made from a supple nonwoven sterilematerial. Generally, the lower surface in contact with the skin of thepatient is adapted to absorb body secretions such as bleeding, while theupper surface is impermeable to the fluids. It is common to usecutaneous drapes iodized or impregnated with an antimicrobial substance,having a residual effect on the microbes present on the skin of thepatient (mainly cutaneous staphylococci). Such drapes are for exampledescribed in WO 2005/110082 (3M), WO 00/71183 (3M), EP 0,812,893(MEDICAL CONCEPTS DEVELOPMENT), EP 0,240,097 (SURGIKOS), EP 0,136,900(SURGIKOS) or FR 2,012,584 (T. J. SMITH et al). These drapes can beadhesive to remain perfectly in place throughout the operation and atthe border closest to the incision area.

Although widely used, these surgical drapes are not fully effectiveinsofar as since they are only cutaneous and do not protect the incisionmargins. Indeed, when the skin is cut, bleeding, even minimal, of thesetissues and prolonged exposure to air cause these incision margins topresent a risk of seeing infections develop, abscesses or bruises, quiteharmful for the health of the patient.

To attempt to resolve this technical problem, the use of a flexibleretractable tubular element that is positioned around the incisionmargins is known from the document WO 99/03416 (MEDICAL CREATIVETECHNOLOGIES). This tubular element is nevertheless difficult to installby the practitioner, because its manipulation is complex. In addition,it is necessary to allow for tubular elements of different diameters soas to able to adapt to the size of the incision made, which isinconvenient and costly.

The document U.S. Pat. No. 4,089,331 (THE KENDALL COMPANY) also attemptsto offer a solution by proposing to use a sterile compress added on theend of a surgical sheet along the edge of the incision window. Thiscompress is arranged to be in a storage position prior to theincision—packed away in a specific pocket or folded up on top of thesheet—and in a position covering the incision margins after theincision. The design of this device appears to be particularly complexbecause there a need for a storage pocket or a device enablingmaintenance of the compress in folded position. In addition, the lengthof the compress cannot be easily adjusted so that the aforementionedcompress can interfere with the operation of the practitioner when it isnot adapted to the depth of the incision. Also, this compress is notparticularly effective against infection or against the formation ofabscess or hematoma.

The document GB 2,221,620 (Johnson & Johnson) discloses a dressingcomprising a fibrous substrate whose surface is coated with apharmacologically acceptable alginate. This type of dressing is not,however, specifically adapted to protect the incision margins andprevent development of infections during a surgical operation.

The existing surgical drapes are not completely effective insofar asthey do not enable effective cleaning of the surgical site. Indeed, whenthe skin is cut, incision secretions appear (bleeding and/or bodilysecretions) that are liable to damage the incision margins and causeinfections of the wall and/or surgical site, particularly nosocomialinfections. In addition, these secretions obscure parts of the operatingsite and thus hamper the smooth running of the surgical operation. It istherefore necessary to evacuate secretions of incision, generally byusing absorbent compress that are changed regularly once they arecompletely infused. The absorption of secretions by compresses leads toadditional maneuvers around the operating site, liable to interfere withthe practitioner's execution of surgical procedures.

The sterile compress, added to the end of the surgical sheet describedin U.S. Pat. No. 4,089,331 cited earlier, does not enable efficientabsorption of the secretions of incision. Indeed, once the compress isfully infused, the absorption of secretions can no longer be carried outso that one must continue to use additional absorbent compress and,therefore, continue to perform the additional maneuvers around thesurgical site.

Known from the document WO2003/018098 (KCI LICENSING INC.) is a systemdesigned to stimulate the healing of a difficult to heal tissue. Thissystem comprises a porous pad introduced into a wound as well as anairtight dressing secured over the pad, hence the achievement of ahermetic seal over the wound. A proximal end of a conduit can beconnected to the dressing, a distal end of this conduit beingconnectable to a negative pressure source, such as an electric pumphoused in a portable housing, or a vacuum wall outlet. A collectorinstalled on the conduit enables the retention of the exudates aspiratedfrom the wound during the application of a negative pressure. Althougheffective, this system is complex and completely covers the wound sothat the practitioner has no access to the incision site. In addition,the system described in document WO2003/018098 (KCI LICENSING INC.) doesnot protect against possible wound nosocomial infections.

Given the disadvantages of the prior art and in particular those of thedevice described in U.S. Pat. No. 4,089,331 (THE KENDALL COMPANY), thesecond technical problem that the invention aims to resolve is toefficiently, rapidly and continually protect the incision marginswithout the practitioner having to perform complex maneuvers.

A third technical problem that the invention aims to resolve is to offera device of the type described in U.S. Pat. No. 4,089,331 (THE KENDALLCOMPANY) capable of protecting the incision margins regularly throughoutthe operation.

A fourth technical problem that the invention aims to resolve is tooffer a device of the type described in U.S. Pat. No. 4,089,331 (THEKENDALL COMPANY) capable of cleaning effectively, regularly, and withoutthe interference for the practitioner, the incision margins as well asthe operating site throughout the surgical operation.

Yet another object of the invention is to offer a device for protectingincision margins enabling prevention of infections of the wall and/oroperating site, and particularly preventing nosocomial infections.

DISCLOSURE OF THE INVENTION

Referring to the first technical problem, the applicant has nowdemonstrated surprisingly that the combination of oxidized regeneratedor non-regenerated cellulose with povidone iodine was providing abacterial inhibition superior to the simple use of oxidized regeneratedor non-regenerated cellulose alone or of povidone iodine alone. It istherefore a synergistic effect that leads to the formation of a new bothvery powerful antibacterial and hemostatic agent.

The solution offered by the invention to resolve the second technicalproblem is a device for active protection of incision margins, designedto prevent development of infections, comprising a surgical drapewherein a total or partial incision window is arranged, and wherein:

-   -   the internal face of the borders of the incision window is        covered by a first layer of a material designed to absorb the        secretions from the incision and a second layer impregnated with        an antiseptic hemostatic ingredient having the purpose of        preventing the development of infections,    -   the second layer partially covers the first layer, the        aforementioned first layer being wider than the aforementioned        second layer,    -   the second layer is arranged so that it can come into contact        with incision margins and cover the top part and the bottom part        of the incision when installing a spacer,    -   the second layer is an oxidized regenerated or non-generated        cellulose cloth combined with povidone iodine.

These technical features enable the practitioner to directly positionthe borders of the incision window at the incision margins toeffectively protect the latter.

The third technical problem is resolved when the second layer is coupledto an element enabling impregnation, on demand, of the hemostaticcontact cloth with povidone iodine. Indeed, the practitioner thus hasthe opportunity to re-impregnate the hemostatic cloth with povidoneiodine, when the quantity of the latter decreases during the course ofthe operation.

The solution offered by the invention to resolve the fourth technicalproblem is a device for active protection of incision margins,comprising a surgical drape wherein a total or partial incision windowis arranged, the borders of the aforementioned incision window beingarranged so that they can come into contact with the incision margins.In accordance with the invention, the internal face of the edges of theaforementioned incision window is covered by a layer of the materialdesigned to absorb the secretions from the incision, the aforementionedlayer being coupled to a tubing connected to a member enablingaspiration of the aforementioned absorbed secretions.

These technical features enable not only draining of the incisionmargin, but also to simply and regularly evacuate the secretions fromthe surgical site. The applicant also was also able to note that such adevice was enabling effective prevention of infections of the walland/or operating site, and particularly nosocomial infections.

PRESENTATION OF THE DRAWINGS

Other advantages and features of the invention will become more apparentupon reading the description of a preferred implementation mode thatwill follow, with reference to the accompanying drawings, made by way ofindicative and not limiting examples and in which:

FIG. 1 a is a schematic view showing the various constituent elements ofthe surgical drape in accordance with the invention,

FIG. 1 b is a schematic view showing the various constituent elements ofFIG. 1 a arranged so as to form the surgical drape in accordance theinvention,

FIG. 2 is a schematic view showing, full surface, the arrangement of thevarious constituent elements of the female part of the surgical drape inaccordance with the invention,

FIG. 3 is a sectional view along A-A of the female part of the surgicaldrape shown in FIG. 2,

FIG. 4 is a schematic view showing, in section, the protection device ofthe invention positioned against the incision margins,

FIG. 5 is a schematic view showing, full surface, the female part of thesurgical drape provided with aspiration elements for the incisionsecretions,

FIG. 6 is a sectional view along B-B of the female part of the surgicaldrape shown in FIG. 5,

FIG. 7 is a schematic showing a view showing, in section, the protectivedevice of the invention positioned against the incision margins andprovided with aspiration elements for the incision secretions.

IMPLEMENTATION MODES OF THE INVENTION

In accordance with the invention, the antibacterial agent ischaracterized by the fact that it comprises as an active ingredient ahemostatic contact cloth having an acidic pH combined with povidoneiodine.

This antibacterial agent is designed to be used in humans and/or animalsin order to protect and/or treat wounds and/or incisions againstbacterial infections. The use of the antibacterial agent is carried outby local application on the wound and/or the incision margins. Forexample, a surgical dressing incorporating the antibacterial agent inaccordance with the invention can be used.

The posology will be adapted depending on the pH of the hemostaticcontact cloth, the possible bacterial infection to be treated and theprofile of the patient. To have a maximum effectiveness, theantibacterial agent optimally comprises between 70 μL and 130 μL ofpovidone iodine, pure or diluted, per 2 cm² to 16 cm² of hemostaticcontact cloth. However, these dosages are not limiting and can be variedaccording to the needs of the person of skill in the art and accordingto the concentration of povidone iodine (0.1%, 1%, 10%, . . . ).

Oxidized regenerated or non-regenerated cellulose from wood pulp, cottonlinters, cotton, ramie, jute, paper or similar materials, and alsoregenerated cellulose is preferably used as hemostatic contact cloth.For example, products known under the name: Surgicel®, Curacel®,Gelitacel®, OKCEL®, Resorcel®, Promogran®, etc. can be used.

The oxidized regenerated or non-regenerated cellulose is a resorptivecontact hemostatic on the application site whose principal action ismechanical. The oxidized regenerated cellulose is a polymer and moreparticularly a polysaccharide composed of D-glucose molecules. Theoxidation by the nitrogen tetroxide results in the oxidation of a partof the primary alcohol functions of the glucose with formation ofglucuronic acid. The product obtained is a polymer of D-glucose andglucuronic acid.

As an example, the oxidation of the oxidized regenerated cellulose formaking Surgicel® is carried out as follows: the oxidation is obtained byreaction of nitrogen tetroxide solution in the perfluorohexane. Thecoils are then washed with 50% Isopropyl alcohol until the achievementof a rinse effluent having PH>3.1. The coils are then rinsed twice in99% isopropyl alcohol, then dried and packaged. The drying allows theelimination of the isopropanol. The gases are stored in a ventilatedcabinet in a controlled atmosphere obtained by a succession of rises intemperature accompanied by partial vacuum operations. The residualisopropanol content is <5 ppm. The dehumidification phase leads to thealmost total elimination of isopropanol. The oxidized non-regeneratedcellulose can come from the oxidation of plant fibers and in particularfrom cotton (Gelitacel®, Okcel®,).

In an implementation variation, the hemostatic contact cloth is oxidizedregenerated or non-regenerated cellulose impregnated with chitosan. Thelatter is a polymer derived from chitin, present in shellfish andcertain plants and fungi. For example, products known under the name of:Chitoflex®, Chitoskin®, BST-Demon®, etc. can be used.

For the povidone iodine, products known under the name: Betadine®,Betaseptic®, Polydine®, Isocline®, Pevidine®, E-Z Scrub®, etc. can beused, for example.

In order to highlight the synergistic effect obtained by the combinationof the hemostatic contact cloth having an acidic pH with povidoneiodine, tests were carried out. These tests enable evaluation, ondifferent bacterial strains, of:

-   -   the antibacterial power of a hemostatic contact cloth having an        acidic pH alone,    -   the antibacterial power of povidone iodine alone,    -   the antibacterial power of hemostatic contact cloth having an        acidic pH combined with povidone iodine.

Methodology:

According to the methodology of the NF EN ISO 20645 (August 2005)standard.

Equipment used:

-   -   Hemostatic contact cloth having an acidic pH:        -   oxidized regenerated cellulose (ORC) cloth made by the            ETHICON® company (SURGICEL®). 2 cm×2 cm in double thickness,        -   oxidized non-regenerated cellulose (ONRC) cloth made by the            GELITA MEDICAL company (GELITACEL®). 2 cm×2 cm in double            thickness,    -   Povidone iodine: 10% Dermal Betadine®. Deposit of 93 μL on the        cloth samples.    -   Bacterial strains:

Pseudomonas aeruginosa CIP 103 467 Methicillin Resistant Staphylococcusaureus CIP 103 811 Staphylococcus aureus CIP 4.83 Escherichia coli CIP54 127 Enterococcus hirae CIP 58.55 Vancomycin-resistant Enterococcusfaecium, CIP 106 915 vanA genotype Vancomycin-resistant Enterococcusfaecium, CIP 104 676 vanB genotype

-   -   Count agar medium: casein tryptone soy agar.    -   Bouillon for the preparation of inocula: casein soy.

Protocol:

-   -   Deposit of 10 mL of supercooled agar in a Petri dish and        solidified at ambient temperature.    -   Deposit of the cloth to be tested on agar:        -   Test cloth.        -   Normalized control cloth (neutral).        -   Test cloth+10% Dermal Betadine®.        -   Normalized control cloth+10% Dermal Betadine®.    -   Preparation of inocula containing 1 to 5×10⁸ CFU/mL for each        strain tested.    -   Inoculation of 1 mL of inoculum in 150 mL of agar at 45° C.    -   Deposit of 5 mL of inoculated agar on the tested cloth, allowing        to solidify.    -   Carrying out the tests in triplicate (test cloth and test        cloth+10% Dermal Betadine®) and a simple test for the controls        (normalized control cloth and normalized control cloth+10%        Dermal Betadine®).    -   Incubation of the agars 24 hours at 37° C.    -   Verification of bacterial growth and determination of the width        of the inhibition area, i.e. the area preserved from bacteria.

The evaluation of the bactericidal effect is based on the absence orpresence of bacterial growth in the contact area between the agar andthe tested cloth, and on the possible appearance of an inhibition areaaround the tested cloth.

ORC Cloth Results:

Evaluation of Inhibition area Bacterial Bactericidal Strains testedTested cloth (mm) Growth effect Pseudomonas Control cloth 0 SignificantInsufficient aeruginosa Control cloth + 0 Significant Insufficient CIP103 467 10% Dermal Betadine ®. ORC cloth 3 non Satisfactory ORC cloth +4 non Satisfactory 10% Dermal Betadine ®. Staphylococcus Control cloth 0Significant Insufficient aureus Control cloth + 0 SignificantInsufficient CIP 4.83 10% Dermal Betadine ®. ORC cloth 2.5 nonSatisfactory ORC cloth + 4.2 non Satisfactory 10% Dermal Betadine ®.Escherichia coli Control cloth 0 Significant Insufficient CIP 54 127Control cloth + 0 Significant Insufficient 10% Dermal Betadine ®. ORCcloth 0.6 non Satisfactory ORC cloth + 2.3 non Satisfactory 10% DermalBetadine ®. Enterococcus Control cloth 0 Significant Insufficient hiraeControl cloth + 0 Significant Insufficient CIP 58.55 10% DermalBetadine ®. ORC cloth 2 non Satisfactory ORC cloth + 3.3 nonSatisfactory 10% Dermal Betadine ®. Methicillin Control cloth 0Significant Insufficient Resistant Control cloth + 0 SignificantInsufficient Staphylococcus 10% Dermal Betadine ®. aureus ORC cloth 2.2non Satisfactory CIP 103 811 ORC cloth + 3.6 non Satisfactory 10% DermalBetadine ®. Enterococcus Control cloth 0 Significant Insufficientfaecium Control cloth + 0 Significant Insufficient CIP 104 476 10%Dermal Betadine ®. ORC cloth 1.2 non Satisfactory ORC cloth + 3.5 nonSatisfactory 10% Dermal Betadine ®. Enterococcus Control cloth 0Significant Insufficient faecium Control cloth + 0 SignificantInsufficient CIP 106 915 10% Dermal Betadine ®. ORC cloth 1.7 nonSatisfactory ORC cloth + 5.5 non Satisfactory 10% Dermal Betadine ®.

Inhi- Evaluation bition of area Bacterial Bactericidal Strains testedTested cloth (mm) Growth effect Pseudomonas Control cloth 0 SignificantInsufficient aeruginosa Control cloth + 0 Significant Insufficient CIP103 467 10% Dermal Betadine ®. ONRC cloth 0 non Satisfactory ONRCcloth + 0.7 non Satisfactory 10% Dermal Betadine ®. StaphylococcusControl cloth 0 Significant Insufficient aureus Control cloth + 0Significant Insufficient CIP 4.83 10% Dermal Betadine ®. ONRC cloth 0.5non Satisfactory ONRC cloth + 2.3 non Satisfactory 10% DermalBetadine ®. Escherichia coli Control cloth 0 Significant InsufficientCIP 54 127 Control cloth + 0 Significant Insufficient 10% DermalBetadine ®. ONRC cloth 0 non Satisfactory ONRC cloth + 1.7 nonSatisfactory 10% Dermal Betadine ®. Enterococcus Control cloth 0Significant Insufficient hirae Control cloth + 0 SignificantInsufficient CIP 58.55 10% Dermal Betadine ®. ONRC cloth 1.5 nonSatisfactory ONRC cloth + 3 non Satisfactory 10% Dermal Betadine ®.Methicillin Control cloth 0 Significant Insufficient Resistant Controlcloth + 0 Significant Insufficient Staphylococcus 10% Dermal Betadine ®.CIP 103 811 ONRC cloth 1 non Satisfactory ORC cloth + 3.2 nonSatisfactory 10% Dermal Betadine ®. Enterococcus Control cloth 0Significant Insufficient faecium Control cloth + 0 SignificantInsufficient CIP 104 476 10% Dermal Betadine ®. ONRC cloth 0.8 nonSatisfactory ONRC cloth + 3 non Satisfactory 10% Dermal Betadine ®.Enterococcus Control cloth 0 Significant Insufficient faecium Controlcloth + 0 Significant Insufficient CIP 106 915 10% Dermal Betadine ®.ONRC cloth 2.2 non Satisfactory ONRC cloth + 4 non Satisfactory 10%Dermal Betadine ®.

CONCLUSION

The combination of oxidized regenerated or non-regenerated cellulosecloth, with 10% Dermal Betadine®, provides a bacterial inhibitionsuperior to the mere use of oxidized cellulose cloth (regenerated ornon-regenerated) alone or 10% Dermal Betadine® alone. These twoconstituents thus act in synergy.

We believe that it is the acidic pH of the hemostatic contact cloth thatenhances the bactericidal effect of the povidone iodine.

Another aspect of the invention relates to a device for activeprotection of incision margins designed to prevent development ofinfections, comprising a surgical drape wherein a total or partialincision window is arranged, the borders of the aforementioned incisionwindow incorporating an antibacterial agent in accordance with theinvention.

This protection device is designed to be used in surgical operations inorder to protect the incision margins. It is installed after theincision operation. The incision to be protected can also be an incisionfor trocar in the setting of laparoscopic surgery.

Referring to FIGS. 1 a and 1 b, the protective device in accordance withthe invention comprises a surgical drape 1 provided with a partial ortotal incision window 2 through which the surgeon carries out his/hersurgery.

The surgical drape 1 can be made in a single piece, but is optimallyformed from a separable male part 1 a and a separable female part 1 b(FIG. 1 a), the incision window 2 being arranged at the junction betweenthe aforementioned male part 1 a and the aforementioned female part 1 b(FIG. 1 b). The use of a surgical drape in two separable partssimplifies its design and its installation by the surgeon.

To adapt the size of the incision window 2 to the size of the incisionto be made, the male part 1 a and the female part 1 b of the surgicaldrape 1 are maintained in position by an adjustable fastening deviceenabling adjustment of the position of the aforementioned male part withrespect to the aforementioned female part and to vary the size of theaforementioned incision window.

Referring to FIGS. 1 a and 1 b, the adjustable fastening device ispreferably formed by fastening lugs 1 c arranged on the male part 1 aand adapted to adhere to the female part 1 b. The adhesive areas canpossibly be protected by a removable protective paper that the operatorwill remove just before the installation. Any other equivalentadjustable fastening device can be used by the person of skill in theart, for example bands of loops and hooks (VELCRO®), or male elementsinserted into female elements.

According to FIGS. 1 a, 1 b and 2, the female part 1 b and the male part1 a are the male have straight borders, with incisions 1 d on each sidearranged so that the edges of the incision window 2 can be easilyintroduced into the surgical margin while maintaining the fixation lugslc outside the body of the patient. The incisions 1 d are optimallyconfigured so that approximately ⅘^(th) of the drape can be introducedinto the surgical margin. According to an advantageous feature of theinvention, the incisions 1 d are precut so that the practitioner canintroduce all or part of the borders of the incision window 2 into thesurgical margin, at his/her discretion.

The surgical drape 1 comprises a base structure 3 made of a sterilenonwoven material of the cellulose wadding type, single layer ormulti-layer. Any other material known to the person of skill in the artand suitable for the making of a surgical drape can be used. The basestructure 3 has a width between 20 cm and 40 cm, a total length between20 and 60 cm and a thickness ranging from 1 mm to 2 mm. However, thesedimensions are not limiting and can be adapted by the person of skill inthe art depending on the type of surgery performed.

In order to effectively isolate the body of the patient from theexternal environment, and particularly from the introduction of acontaminated fluid, the upper surface of a surgical drape 1 iswaterproofed. This waterproofing can be made using a plastic film, amaterial impervious to liquids, a hydrophobic material or any othermaterial suitable to the person of skill in the art.

In FIGS. 2 and 3, only the female part 1 b of the surgical drape 1 isrepresented. However, the features shown also apply to the male part 1 aor to the surgical drape 1 in the case where it is made in one piece.

In accordance with the invention and referring to FIGS. 1 a and 1 b, theinternal face of the borders of the incision window 2 is covered by ameans 4 for protecting the incision margins.

In accordance with the invention, this means of protection 4 comprises alayer 4 b impregnated with an antiseptic-hemostatic and/or bactericidaland/or antibacterial and/or antibiotic and/or acidic ingredient.

According to an advantageous feature of the invention shown in FIG. 2and enabling optimization of the protection of the incision margin, themeans of protection 4 comprises a first layer 4 a of a material designedto absorb the secretions from the incision and the second layer 4 bimpregnated with a antiseptic-hemostatic and/or bactericidal and/orantibacterial and/or antibiotic and/or acidic ingredient.

Referring to FIG. 4, the second layer 4 b is arranged so that itcontacts the incision margins 5 when setting up the surgical drape 1around the incision. By “incision margins”, it is meant that, in themeaning of the present invention, the cutaneous plane 5 a and/or thesubcutaneous plane 5 b and/or the bone, muscular or fascial plane 5 c.

According to an advantageous feature of the invention shown in thefigures, the first layer 4 a and the second layer 4 b are arrangedimmediately adjacent to the borders of the incision window 2 to enablethe surgeon to protect the incision margin 5 quickly by the simplecrimping of the aforementioned edges in the body of the patient.

And in order to fully protect the incision margins 5, the second layer 4b is advantageously arranged so that comes into contact with theaforementioned margins and covers the top part and the bottom part ofthe incision during the installation of a spacer 6. Indeed, throughoutthe operation, the latter impacts and perfectly maintains the protectivedevice object of the invention in position against the margins 5,without the edges of the incision window 2 interfering with the surgeon.

The first layer 4 a can be of any conventional type. The absorbentmaterials commonly encountered are for example pulp, highly absorbentpolymers, absorbent foam materials, and absorbent nonwoven fibers. It ispossible to combine different materials in order to have differentproperties with respect to the liquid absorption capacity, distributioncapacity and storage capacity. The material used is preferably, but notnecessarily, a sterile thick absorbent compress of the HYDREX® type.

The second layer 4 b is preferably made by a hemostatic contact clothhaving an acidic pH combined with povidone iodine. Preferably used, as ahemostatic contact cloth, is regenerated (Surgicel®, Curacel®,Resorcel®, Promogran®, etc.) or non-regenerated (Gelitacel®, Curacel®,Okcel®) oxidized cellulose. In an implementation variation, thehemostatic contact cloth is oxidized cellulose, regenerated ornon-regenerated, impregnated with chitosan (Chitoflex®, Chitoskin®,BST-Demon®, etc.). For the povidone iodine, known products such as, forexample, Betadine®, Betaseptic®, Polydine®, Isodine®, Pevidine®, E-ZScrub®, etc. can be used.

However, the second layer 4 b can also be made by using a sterilecompress of the HYDREX® type impregnated with an antiseptic-hemostaticand/or bactericidal and/or antibacterial and/or antibiotic and/or acidicingredient. Any other equivalent material or coating adapted to beimpregnated with such ingredients can be used by the person of skill inthe art. This impregnation is for the purpose of preventing developmentof infections, parietes abscesses or hematomas. Among the utilizableimpregnation ingredients, hemostatic ingredients, hydrogen peroxide,silver ion-based antiseptics, calcium alginate, Piliostigma Reticulatum,bacteriostatic agents, bactericidal agents, antibiotic molecules, acidicpH molecules, etc. can be cited as non-limiting example. These variousimpregnation ingredients can be used alone or in combination.

The second layer 4 b totally or partially covers the first layer 4 a.Referring to FIGS. 2 and 3, the first layer 4 a is wider than the secondlayer 4 b so that the first layer can effectively absorb and storebleeding or other bodily secretions. In practice, the first layer 4 ahas a length substantially equal to the width of the surgical drape 1(and the male 1 a and female 1 b part), a width of approximately 10 cmand a thickness ranging from 4 mm to 6 mm. The second layer 4 b also hasa length substantially equal to the width of the surgical drape 1 (andthe male 1 a and female 1 b part), a width of approximately 5 cm and athickness ranging from 4 mm to 6 mm. However, these dimensions are notlimiting and can be adapted by the person of skill in the art dependingon the type of surgery performed.

Referring to FIGS. 2 to 4, the second layer 4 b is advantageouslycoupled to an element 7 enabling impregnation, on demand, of thehemostatic contact cloth with povidone iodine.

This element 7 also enables impregnation of the sterile compress thatcan form the second layer 4 b, with an antiseptic-hemostatic and/orbactericidal and/or antibacterial and/or antibiotic and/or acidicingredient.

In practice, the second layer 4 b is coupled to a tubing 7 a connectedto a member 7 b enabling distribution, on demand, of povidone iodine (orany other active agent: a antiseptic-hemostatic and/or bactericidaland/or antibacterial and/or antibiotic and/or acidic agent), theaforementioned tubing comprising, in its distal part, perforationsconfigured so that the povidone iodine (or any other active agent) caninfuse the second layer.

The tubing 6 a is advantageously placed between the second layer 4 b andthe base structure 3. It can possibly be embedded in the first layer 4a. This tubing 7 a enables an irrigation of the second layer 4 b, andtherefore of the surgical incision site. This tubing 7 a is perforatedon a distal part, and on its proximal part; it is terminated by aconnector of the Luer-lock® type connectable to a syringe or any otherdispensing member 7 b. In particular, in place of the syringe, avolumetric pump configured to irrigate the tube 7 a, continuously and/orat the demand of the practitioner, can be used.

The instillation of an active ingredient (povidone iodine or other), canbe carried out by this route, thus infusing the second layer 4 b. Theseinjections can be repeated over time, as the drape 1 is left in place.

The connection enabling the injection is preferably situated to theright of the male part 1 a and to the left of the female part 1 b, sothat the two routes of injection are situated on the same side when thetwo parts are installed on each of the respective surgical incisionmargin 5. A Y-like double channel can be connected to these twoinjection sites in order to facilitate the instillations and in order toirrigate the two parts 1 a and 1 b by a single injection site.

In FIGS. 5 and 6, only the female part 1 b of the surgical drape isshown. However, the features shown apply equally to the male part 1 a orto the drape 1 in the case where it is made in single piece.

Referring to FIGS. 5 to 7, the internal face the borders of the incisionwindow 2 can be coupled to an element 8 enabling the aspiration ofsecretions from the incision (bleeding and/or bodily secretions and/orfree adipocyte magma and/or possible particles of glove talc, . . . ) atthe incision margins 5. The practitioner thus has the option of drainingthe incision margin 5 and regularly evacuating secretions from thesurgical site.

This feature must be understood as being independent of the design ofthe device object of the invention (a drape 1 made in a single piece orin two pieces) and in particular independent of the presence or not ofthe second layer 4 b and of the antiseptic properties or not of theaforementioned device.

In practice, the first layer 4 a designed to absorb the incisionsecretions is coupled to a tubing 8 a connected to member 8 b enablingaspiration of the aforementioned absorbed secretions and thus ensuringthe drainage of the incision margins 5.

In the case where the first layer 4 a is the thick sterile absorbentcompress type, the tubing 8 a is advantageously embedded in theaforementioned compress. If the first layer 4 a is the type made from anabsorbent foam material, the tubing 8 a can be embedded in theaforementioned foam material or be placed against one of the faces ofthe aforementioned first layer, the vacuum created by the member 8 benabling aspiration of all the bleeding and/or absorbed bodilysecretions.

The tubing 8 a is advantageously perforated on a distal part and on itsproximal part. It is terminated by a tip designed to be connected to theaspiration member 8 b. In practice, a Luer-lock® type connector,connectable to a pump or any other aspiration member 8 b, can be used.In practice, an electric pump housed in a portable housing or a vacuumwall outlet can be used. The aspiration can be performed continuouslyand/or at the demand of the practitioner.

The tubing 8 a can be single or multiple. In the latter case, the tubing8 a has several branches arranged so as to homogenize the aspiration ofincision secretions absorbed by the first layer 4 a.

The connection enabling the aspiration is preferably situated to theright of the male portion 1 a and to the left of the female portion 1 b,so that the two suction channels are situated on the same side when thetwo parts are installed on each of the respective incision margins 5. AY-like double channel can be connected to these two aspiration sites inorder to be able to aspirate the incision secretions at the two parts 1a and 1 b by a single aspiration site.

The tubing 8 a enabling aspiration of the incision secretions absorbedby the first layer 4 a can be the same tubing 7 a enabling impregnationof the second layer 4 b with an active ingredient. In an implementationvariation, the tubings 7 a and 8 a are distinct.

The invention claimed is:
 1. A device for active protection of incision margins designed to prevent development of infections, comprising a surgical drape wherein a total or partial incision window is arranged, the incision window defining borders, characterized by the fact that the borders of the incision window incorporate an antibacterial agent comprising as an active ingredient a hemostatic contact cloth having an acidic pH combined with povidone iodine.
 2. A device according to claim 1, wherein: an internal face of the borders of the incision window is covered by a first layer of a material designed to absorb secretions from the incision and a second layer impregnated with an antiseptic hemostatic ingredient designed to prevent the development of infections, the second layer partially covers the first layer, the first layer being wider than the second layer, the second layer is arranged so that it can come into contact with incision margins, the second layer is an oxidized regenerated or non-regenerated cellulose cloth combined with povidone iodine.
 3. A device according to claim 2, wherein the second layer is coupled to an element enabling impregnation, on demand, of the hemostatic contact cloth with povidone iodine.
 4. A device according to claim 3, wherein the second layer is coupled to a tubing connected to a member enabling distribution, on demand, of povidone iodine, the tubing comprising, in its distal part, perforations configured so that the povidone iodine can infuse the second layer.
 5. A device according to claim 1, wherein the borders of the incision window are arranged so that they can come into contact with the incision margins, an internal face of the edges of the window being covered by a layer of a material designed to absorb the secretions from the incision, the layer being coupled to a tubing connected to a member enabling aspiration of the absorbed secretions.
 6. A device according to claim 5, wherein the layer designed to absorb the incision secretions is a thick, sterile, absorbent compress, the tubing being embedded in the compress.
 7. A device according to claim 5, wherein the layer designed to absorb the incision secretions is an absorbent foam material, the tubing being embedded in the foam material.
 8. A device according to claim 5, wherein the layer designed to absorb the incision secretions is an absorbent foam material, the tubing being placed against a face of the layer.
 9. A device according to claim 5, wherein the tubing is perforated on a distal part, and on its proximal part; it is terminated by a nozzle designed to be connected to the aspiration member.
 10. A device according to claim 5, wherein the tubing comprises several branches arranged so as to homogenize the aspiration of incision secretions absorbed by the layer. 